Principal Investigator/Program Director (Last. First, Middle): Greenland, Philip DESCRIPTION: See instructions.State the application's broad, long-term objectives and specific aims, making referenceto the health relatednessof the project (i.e.. relevanceto the mission of the agency). Describe concisely the research design and methods for achieving these goals. Describe the rationale and techniques you will use to pursue thesegoals. In addition, in two or three sentences, describe in plain, lay languagethe relevance of this research to public health. If the application is funded, this description, as is. will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEEDTHESPACE PROVIDED. The overall goal of this CTSA program is to create an integrated, efficient, and proactive academic home to promote, facilitate, and transform clinical and translational research at Northwestern University (NU) and its affiliated clinical institutions. The program includes participation by six NU schools and all four of its affiliated hospitals. The focal point of this application is the new Northwestern University Clinical and Translational Sciences (NUCATS) Institute, a physical and intellectual home for its leaders, member faculty, and research trainees. The major principle driving this program of teaching, research development, and infrastructureis that an integrated and focused research organization can propel the translation of research findings into mproved patient care and population health more rapidly and effectively than the decentralized approaches to clinical and translational research that now exist in most academic institutions. The NU CTSA application has 4 goals: 1. Provide new, broad-based, and coordinated leadership to accelerate translation of ideas into health-care solutions within the Northwestern University community and beyond by systematically studying and promoting multidisciplinary research interactions in the context of new research teams and, in so doing, to gain fundamental insights into the process of clinical/translationalcollaboration 2. Create and support a new and expanded set of research and training resources (tools) that will support new discoveries, new technology development, and translational team-based research3. Educate and encourage a broad range of scientists.and health care providers to study and solve important health problems in a team-based environment at the interfaces between fundamental science, clinical medicine, and the community 4. Evaluate the impact of the new tools and new collaborations that we have developed in order to continuously improve our outcomes. The faculty leaders chosen to direct the Institute and its functional components have the experience, authority, and committed time to administer the new home for clinical and translational research. The Program benefits from an outstanding research environment and tremendous institutional support. PERFORMANCE SITE(S) (organization,city, state) Northwestern University, Evanston and Chicago, IL Children's Memorial Hospital, Chicago, IL Evanston Northwestern Healthcare, Evanston, IL Northwestern Medical Faculty Foundation/Chicago, IL Northwestern Memorial Hospital, Chicago, IL Rehabilitation Institute of Chicago, Chicago, IL PHS 398 (Rev. 04/06) Page 2 Form Page 2 Principal Investigator/Program Director (Last, First, Middle): Greenland, Philip KEY PERSONNEL. See instructions. Use continuationpages as needed to providethe required information in the format shown below. Start with Principal Investigators). List all other key personnel in alphabeticalorder, last name first Name eRA Commons User Name Organization Role on Project Greenland, Philip PGREENLAND NU-FSM [unreadable] Principal Investigator Lowe, William L. NU-FSM Deputy Director, CTSA Backman, Vadim Backman 'ENHand NU Bioeng Dir,TTR Baker. David NU and NMFF Prog Dir,CERC - PBR-P Binns, Helen CMH and NU-FSM Dir, CERC - PBRCMHN Bishop, Virginia NU-FSM Prog Dir, CERC - CBPR-P Cella, David ENH and NU-FSM Co-Leader, TOP Chang, Rowland rwchang NU-FSM Program Leader, TRIP Channin, David DAVIDCHANNIN NU-FSM Assc Dir, NUBIC Chisholm, Rex RCHISHOLM NU-FSM Center Director, NUBIC OTHER SIGNIFICANT CONTRIBUTORS Name . . [unreadable] - ' Abecassis, Michael Allee, Ruth Anderson, Steven Becker, Adam Benedict, Albert Chase-Landsdale, Lindsey Distemoff, John. Dooley, Sharon Dubocovich, Margarita Dyer, Alan Eljas, Sherman Feinglass, Joseph Green, Thomas Harrison, Dean Hendrix, Mary^J. C, Holmgren, Robert Organization [unreadable] NU-Feinberg School of Medicine Northwestern University NU-Feinberg School of Medicine Children's Memorial Hospital The Center for Neighborhood Technology Northwestern University NU-Feinberg School of Medicine NU-Feinberg School of Medicine NU-Feinberg School of Medicine NU-Feinberg School of Medicine NU-Feinberg School of Medicine NU-Feinberg School of Medicine Children's Memorial Hospital Northwestern Memorial Hospital Children's Memorial Hospital NU-Feinberg School of Medicine Role on Project T32 Education Steering Committee Tracking &Evaluation Committee Curriculum Advisory Committee CERC Advisory Committee CERC Advisory Committee Clin and Transl Sci Rsch Council Education Advisory Committee MSCI Admissions Advisory Comm MSCI Admissions Advisory Comm Curriculum Advisory Committee K12 Education Steering Committee CERC Advisory Committee MSCI Admissions Advisory Comm Steering and Gov Committee Clin and Transl Sci Rsch Council T32 Education Steering Comm. Human Embryonic Stem Cells Q No Q Yes If the proposedproject Involves human embryonic stem cells, list below the registration number of the specific cell llne(s) from the following list http://StemcellS.nih.qov/reQistrv/index.asD. Use continuation pages as needed. If a specific line cannot be referenced at this time, Include a statement that one from the Registry will be used. Cell Une PHS 398 (Rev. 04/06) Page 3 Form Page 2-contlnued Principal Investigator/Program Director (Last, First, Middle): Greenland, Philip KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator(s). List all other key personnel In alphabetical order, last name first. Name eRA Commons User Name Organization Role on Project Chiu, Brian Brianchiu NU-FSM Epi Investigator, TRIP Christoffel, Katherine Kaufer KKC CMH and NU-FSM Center Director, CERC Contractor, Noshir NU-McCormick Professor, RTS Dunaif, Andrea DUNAIF NU-FSM Center Director, CCR Egmon, Jean NU-KSM and SESP Co-Director, RTS Engman, David Davidengman NU-FSM and NMH Dir, CCRE-T32 Epstein, Leon CMH and NU-FSM Asst Dir CMH, CRSP Falk-Krzesinski, Holly HFALKKRZESINSKI NU Director, RTS Glucksberg, Matthew NU-McCormick Program Leader, TOP Huang, Chiang-Ching NU-FSM Program Director. NUBIC Huang. Jie NU-FSM Biostats Investgr, TRIP Johnson, David NU-FSM Assc Dir, RDP Jovanovic, Borko BJOVANOVIC NU-FSM Biostats Investgr, TRIP Kadish, Alan NU-FSM Assc Dir, CRSP Kessler, John jakessler NU-FSM Co-Leader, TOP Kho.Abel NU-FSM Program Director, NUBIC Kibbe, Warren Wakibbe NU-FSM Assc Dir, NUBIC Kuiken, Todd Tkuiken RIC and NU-FSM Co-Director, RDP Linehan, John NU-FSM "and McCormick Center Dir. Transl Innov LOffler, Alicia NU-KSM Co-Leader, TOP Losordo, Douglas dlosordo NU-FSM. Co-Director, RDP McDermott, Mary McGrae MDM608 NU-FSM Program Director, CRSP McGaghie, William McGaghiew NU-FSM Director, Track and Eval Morimoto, Richard RMORIMOTO NU-WCAS Center Director, CCRE Muller, William wamuller NU-FSM . Program Leader. TTR O'Halloran, Thomas TOHALLORAN NU-WCAS. Program Co-Leader,TTR Pope, Richard NU-FSM Dir, CCRE &K12 Prog. Ramsey-Goldman, Rosalind ramseygoldman NU-FSM Assc Dir, CRSP Robertson, Russell NU-Feinberg School of Medicine Dir ENH, CERC Schnaper, H.William Schnaper NU-FSM Director, CCRE - PSTP Shea, Lonnie LONNIESHEA NU-McCormick Bloeng Core Dir, TTR Smith, Lewis LJSMITH NU-FSM Dir, RSP Scares, Marcelo Bento CMH Prog Dir CMH, NUBIC Stupp, Samuel S-Stupp NU-McCormick Co-Leader, TOP Thompson, Leigh NU Professor, RTS Uzzi, Brian NU-KSM Co-Dir. Track and Eval Welty, Leah NU-FSM Biostats Investigator, TRIP PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page_4 Continuation Format Page Principal Investigator/Program Director (Last. First Middle): Greenland, Philip OTHER SIGNIFICANT CONTRIBUTORS CONTINUED Name Organization Role on Project Hughes-Halbert, Chanita Univ of Penn, Philadelphia CERC Advisory Committee Israel. Barbara Univ of Michigan, Ann Arbor CERC Advisory Committee Jain, Dipak NU-Kellogg School of Management Steering and Gov Committee Jameson, James Larry NU-Feinberg School of Medicine Steering and GovCommittee Kaufman, Dixon NU-Feinberg School of Medicine Education Advisory Committee Landsberg, Lewis NU-Feinberg School of Medicine Steering and GovCommittee Lee, Chung NU-Feinberg School of Medicine Education Advisory Committee Lee, Sandra NU-Feinberg School of Medicine Curriculum AdvisoryCommittee Leis, Jonathan NU-Feinberg School of Medicine Clin and Transl Sci Rsch Council Leonard, William NU-Feinberg School of Medicine Education AdvisoryCommittee Licht, Jonathan NU-Feinberg School of Medicine Clin and Transl Sci Rsch Council Linzer, Daniel NU-Weinberg College of Arts and Set Steering and Gov Committee Longnecker, Richard NU-Feinberg School of Medicine Education AdvisoryCommittee Luhing, Paul NU-Feinberg School of Medicine CERC AdvisoryCommittee Magoon, Patrick Children's Memorial Hospital Steering and Gov Committee Matouschek, Andreas NU-Feinberg School of Medicine Education Advisory Committee Mayo, Kelly NU-Feinberg School of Medicine Education Advisory Committee McGee. Richard NU-Feinberg School of Medicine Education Advisory Committee Meade, Thomas NU-Feinberg School of Medicine Clin and Transl Sci Rsch Council Mesulam, Marek-Marsel NU-Feinberg School of Medicine Clin and Transl Sci Rsch Council Metzger, Boyd NU-Feinberg School of Medicine MSCI AdmissionsAdvisoryComm Miller, Jeffrey NU-Feinberg School of Medicine Steering and Gov Committee Mirkin, Chad NU-McCormick School of Engineering Clin and Transl Sci Rsch Council Moore, C. Bradley Northwestern University Steering and GovCommittee Morris, Aldon Douglas NU-Weinberg School of Arts and Sci Steering and Gov Committee Neaman, Mark Evanston Northwestern Healthcare Steering and Gov Committee P'Keefe, Barbara NU-School of Communication Steering and Gov Committee Ottino, Julio NU-McCormick School of Engineering Steering and Gov Committee Felling, Jill NU-Feinberg School of Medicine Clin and Trans! Sci Rsch Council Peterson, Penelope NU-School of Education &Social Policy Steering and GovCommittee Rammohan, Meenakshi Northwestern Memorial Hospital Education AdvisoryCommittee Rosen, Steven NU-Feinberg School of Medicine Steering and Gov Committee Rymer, William NU-Feinberg School of Medicine .Clin and Transl Sci Rsch Council Sanders, Dale Northwestern Medical Faculty Foundation Division Co-Director, NUBIC Schroeder, James Northwestern Medical Faculty Foundation Steering and Gov Committee Selker, Leopold Evanston Northwestern Healthcare Clin and Transl Sci RschCouncil Silverman, Richard NU-Weinberg School of Arts and Sci Clin and Transl Sci Rsch Council Smith, Joanne Rehabilitation Institute of Chicago Steering and Gov Committee Stern, Scott NU-Kellogg School of Management Clin and Transl Sci Rsch Council PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Pagejj Continuation Format Page Principal Investigator/Program Director(Last, First. Middle): Greenland, Philip OTHER SIGNIFICANT CONTRIBUTORSCONTINUED Sunshine, Eugene Northwestern University Surmeier, James NU-Feinberg School of Medicine Teplin, Linda NU-Feinberg School of Medicine Thomas, John X NU-Feinberg School of Medicine Turek. Fred NU-Feinberg School of Medicine Van Eldik, Linda NU-Feinberg School of Medicine Wachtel, Andrew NU-The Graduate School Weiss, Kevin Veteran's Affairs and NU-FSM Whitman, Steven Sinai Urban Health Institute Wong, Patrick ChunMan NU-lnstitute for Neuroscience Woodruff,Theresa NU-Feinberg School of Medicine Woolley, Catherine NU-Feinberg School of Medicine Steering and Gov Committee Clin and Transl Sci Rsch Council CERC AdvisoryCommittee Tracking and Evaluation Comm Clin and Transl Sci Rsch Council Clin and Transl Sci Rsch Council Steering and Gov Committee Clin and Transl Sci Rsch Council Epidemiologist Consultant, TRIP Clin and Transl Sci Rsch Council Clin and Transl Sci Rsch Council T32 Education Steering Committee PMS 398/2590 (Rev. 09/04. Reissued 4/2006) Page J5 Continuation Format Page Principal Investigator/Program Director (Last. First, Middle): Greenland Philip RESEARCH GRANT TABLE OF CONTENTS Pago.Numbers A. Face Page 1 B. Description. Performance Sites, Key Personnel 2 C. Table of Contents 7 D. Budget for U54, K12, and T32 Components Composite Budget for the U54 Project (Initial Budget Period and Summary Budget Period) 9 Detailed Budget for the NU:CATS Institute Administration Budget 11 Detailed Budget for Research Discovery Program 23 Detailed Budget for Technology Development Program 30 Detailed Budget for Translational Research Incubator Program ." 37 Detailed Budget for Translational Technologies and Resources Program 47 Detailed Budget for Clinical Research Support Program 52 Detailed Budget for Regulatory Support Program 135 Detailed Budget for Biomeclical Informatics Center 142 Detailed Budget for Center for Clinical Research Education 151 Detailed Budget for Community Engagement and Research Center 159 Detailed Budget for Office of Research Team Support 189 Detailed Budget for Tracking and Evaluation Program '. 194 Detailed Budget for K12 Component 198 ' Detailed Budget for T32 Component :;201 Composite Budget for Entire Program (Initial Budget Period) 202 Composite. Budget for the Entire Program (All Years) 203 E. Biographical Sketch... 204 Index of Biographical Sketches 204 Principal Investigator/Program Director : 206 Other Biographical Sketches: Key Personnel and Significant Contributors 210 F. Institutional Clinical and Translational Science Award Program i (1) Introduction to the Resubmission 670 (1.2) Overall Integrated Approach/Governance 674 Program functions (2.1) Center for Translational Innovation.. 705 (2.1.2) Research Discovery Program;'. '. 707 (2.1.3) Technology Development Program.... '. 726 (2.1.4) Translational Research Incubator Program 747 (2.1.5) Translational Technologies and Resources Program 767 (2.2.1) Clinical Research Support Program 787 (2.2.2) Regulatory Support Program 813 (2.3) Biomedical Informatics Center :..... 830 (2.4) Center for Clinical Research Education 848 PHS 398/2590 (Rev. 09/64;Reissued4/2006) Page 7 Continuation Format Page